MAUDE Adverse Event Report: ETHICON INC. VICRYL SUTURE 18"(45CM) 3-0 UND; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	J497G
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Investigation summary: it was reported that the device had pull off - suture needle.Four sealed boxes with twelve unopened samples each of product code j497, lot mjk059 were returned for analysis.As total 48 unopened samples were received for evaluation.The issue sample was not returned.During the visual inspection of thirteen samples, no defects were found on the packages.The samples were opened, and the swage and attachment area were noted to be as expected.The sutures were dispensed without problems and examined along of the strands and no defects were observed.A functional test was performed and the pull force were above the minimum requirements.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.Per the condition of the samples, no performance pull off suture needle was found, and the tested samples met the finished goods requirements.Representative samples returned to support investigation of 4 device issues captured in reports 2210968-2019-82593, 2210968-2019-82594, 2210968-2019-82595, and 2210968-2019-82596.Analysis results have been included in reports for each.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on an unknown date and suture was used.During the procedure, the needle fell off the suture.It is unknown if another like device was used to complete the procedure.There were no adverse consequences for the patient reported.No additional information was provided.

• Brand Name: VICRYL SUTURE 18"(45CM) 3-0 UND
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8684955
• Report Number: 2210968-2019-82595
• Device Sequence Number: 2308753
• Product Code: GAM
• UDI-Device Identifier: 10705031040625
• UDI-Public: 10705031040625
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K022269
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2023
• Device Catalogue Number: J497G
• Device Lot Number: MJK059
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/14/2019
• Initial Report FDA Received Date: 06/10/2019
• Patient Sequence Number: 1